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Reimbursement / Regulatory

Nvision Gains FDA Clearance for PEEK Hammertoe System -

Nvision Biomedical Technologies received FDA 510(k) clearance to market Vector™, the first foot/ankle implant made from PEEK-OPTIMA™ HA Enhanced polymer from Invibio Biomaterial Solutions. The device is also reportedly the first lower extremity implant to use Structural Encoding® to enable Unique Device Identification. Structural Encoding, licensed from Watershed Idea Foundry, is able to embed the entire history of the device; this data can be read by simple x-ray imaging. This clearance represents Nvision's entry to the extremities trauma market, expanding from its previous focus on spine. Vector enables a standard surgical technique that allows direct drilling and the exact placement of the implant, and is an alternative to the conventional K-wire implant procedure to treat hammertoe. (Nvision Biomedical Technologies, 3/12/19)